Sitagliptin & Simvastatin

Sitagliptin/simvastatin is a prescription medication used to treat type 2 diabetes and high cholesterol in adults. 

Sitagliptin/simvastatin is a single tablet containing two prescription drugs. Sitagliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which help lower blood sugar levels. Simvastatin belongs to a group of drugs called HMG-CoA reductase inhibitors, which help lower cholesterol levels.

This medication comes in tablet form and is taken once daily in the evening.

Common side effects include upper respiratory tract infection, stuffy or runny nose, sore throat, and headache.

Sitagliptin/simvastatin is a prescription medicine used to treat type 2 diabetes and high cholesterol in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Sitagliptin & Simvastatin may be found in some form under the following brand names:

• Juvisync

Serious side effects have happened in people taking sitagliptin/simvastatin.

• See "Drug Precautions".
• myopathy (muscle weakness) and rhabdomyolysis (muscle breakdown). Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness while you take sitagliptin/simvastatin.
  • Muscle problems, including muscle breakdown, can be serious in some people and on rare occasions may cause kidney damage that can lead to death.
  • The risk of muscle breakdown is greater at higher doses of sitagliptin/simvastatin.
  • The risk of muscle breakdown is greater in people 65 years of age and older, females, and people with kidney or thyroid problems.
• liver problems. Your doctor should do blood tests to check your liver before you start taking sitagliptin/simvastatin and if you have any symptoms of liver problems while you take sitagliptin/simvastatin. Call your doctor right away if you have the following symptoms of liver problems:
  • feel tired or weak
  • loss of appetite
  • upper belly pain
  • dark urine
  • yellowing of your skin or the whites of your eyes
• kidney problems, sometimes requiring dialysis
• low blood sugar (hypoglycemia). If you take sitagliptin/simvastatin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use sitagliptin/simvastatin. Signs and symptoms of low blood sugar may include:

• headache
• drowsiness
• weakness
• dizziness
• confusion
• irritability
• hunger
• fast heart beat
• sweating
• feeling jittery

• Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking sitagliptin/simvastatin and call your doctor right away. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

The most common side effects of sitagliptin/simvastatin include:

• upper respiratory infection
• stuffy or runny nose and sore throat
• headache
• stomach pain
• constipation
• nausea

Sitagliptin/simvastatin may cause other side effects, including:

• swelling of the hands or legs. Swelling of the hands or legs can happen if you take sitagliptin/simvastatin in combination with rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.
• joint pain
• muscle pain
• alterations in some laboratory blood tests
• liver problems (sometimes serious)
• nausea
• dizziness
• tingling sensation
• depression
• trouble sleeping
• poor memory
• erectile dysfunction
• breathing problems including persistent cough and/or shortness of breath or fever.

These are not all the possible side effects of sitagliptin/simvastatin. For more information, ask your doctor or pharmacist.

Tell your doctor if you have any side effect that bothers you, is unusual or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

• It is especially important to tell your doctor if you take:
  • blood thinners such as Coumadin (warfarin)
  • fibric acid derivatives (such as fenofibrate)
  • amiodarone (a drug used to treat an irregular heartbeat)
  • the following medicines used to treat high blood pressure, chest pain with heart disease, or other heart problems:
    • verapamil
    • diltiazem
    • amlodipine
    • ranolazine
  • large amounts of grapefruit juice (more than 1 quart daily)
  • colchicine (a medicine used to treat gout)
  • voriconazole (an anti-fungal medicine)
  • large doses of niacin or nicotinic acid
  • niacin or a niacin-containing product, as this may increase your risk of muscle problems, especially if you are Chinese.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Sitagliptin/simvastatin includes a statin medication called simvastatin. Statin medications carry a rare but serious risk of:

• liver damage
• memory loss or confusion
• increase in blood sugar levels (hyperglycemia)
• type 2 diabetes
• immune-mediated muscle breakdown

Certain statins can increase risk of muscle weakness as well. It is important to consult your physician to discuss the benefits and risks associated with using this medication.

Serious side effects can happen in people taking sitagliptin/simvastatin, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.

Before you start taking sitagliptin/simvastatin:

Tell your doctor if you have ever had:

• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels
• kidney problems

Stop taking sitagliptin/simvastatin and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

This medication may cause severe and persistent joint pain. If you experience severe and persistent joint pain, contact your doctor right away. Do not stop taking your medication. Your doctor will decide if your medication is the possible cause of severe  joint pain and will discontinue the drug if appropriate.

Do not take sitagliptin/simvastatin if you: 

• are allergic to any of the ingredients in sitagliptin/simvastatin. Symptoms of a serious allergic reaction to sitagliptin/simvastatin may include:

• rash
• raised red patches on your skin (hives)
• swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

• take certain medicines such as:
  • anti-fungal medicines including:
    • itraconazole
    • ketoconazole
    • posaconazole
  • HIV protease inhibitors, including:
    • indinavir
    • nelfinavir
    • ritonavir
    • saquinavir
    • tipranavir
    • atazanavir
  • certain hepatitis C virus protease inhibitors, including:
    • boceprevir
    • telaprevir
  • certain antibiotics, including:
    • erythromycin
    • clarithromycin
    • telithromycin
  • nefazodone
  • a fibrate medicine for lowering cholesterol called gemfibrozil
  • cyclosporine
  • danazol. Ask your doctor if you are not sure whether your medicine is listed above.
• have active liver disease or repeated blood tests indicating possible liver problems.
• are pregnant or think you may be pregnant, or you are planning to become pregnant.
• are a woman of childbearing age, you should use an effective method of birth control to prevent pregnancy while using sitagliptin/simvastatin.
• are breastfeeding or plan to breastfeed.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of sitagliptin/simvastatin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take sitagliptin/simvastatin, tell your doctor if you:

• have or have had inflammation of your pancreas (pancreatitis).
• have kidney problems.
• drink substantial quantities of alcohol or ever had liver problems.
• have any other medical conditions.
• are taking drugs that prevent blood clots, such as warfarin.
• are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sitagliptin/simvastatin falls into category X. It has been shown that women taking sitagliptin/simvastatin during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if the active ingredients in simvastatin and sitagliptin are excreted in human breast milk.

• Take one sitagliptin/simvastatin tablet each day, in the evening, exactly as your doctor tells you.
• Take sitagliptin/simvastatin tablets whole. Do not break, cut, crush, dissolve, or chew sitagliptin/simvastatin tablets before swallowing. If you cannot swallow tablets whole, tell your doctor.
• Your doctor may tell you to take sitagliptin/simvastatin along with other diabetes medicines. Low blood sugar can happen more often when sitagliptin/simvastatin is taken with certain other diabetes medicines. 
• If you take too much sitagliptin/simvastatin, call your doctor or go to the nearest hospital emergency room right away.
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
• Check your blood sugar as your doctor tells you to.
• Stay on your prescribed diet and exercise program while taking sitagliptin/simvastatin.
• Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
• Your doctor will monitor your condition with regular blood tests, including your blood sugar levels, hemoglobin A1C, and cholesterol levels, and to check for side effects.
• Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with sitagliptin/simvastatin.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• how you respond to this medication
• other medications you are taking
• your renal function

The recommended starting dose/dose range of simvastatin and sitagliptin is 100 mg/40 mg per day.

The dose may be reduced based on your renal function.

If you take too much sitagliptin/simvastatin, call your doctor or go to the nearest hospital emergency room right away.

Store sitagliptin/simvastatin at 68°F to 77°F (20°C to 25°C). Store in a dry place with cap tightly closed.

Keep sitagliptin/simvastatin and all medicines out of the reach of children.